Scp776 for Stroke
(ARPEGGIO Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Silver Creek Pharmaceuticals
Prior Safety Data
Trial Summary
What is the purpose of this trial?A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke
Do I have to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking a chronic anticoagulant like warfarin or apixaban.
What data supports the idea that Scp776 for Stroke is an effective treatment?
The available research does not provide specific data supporting the effectiveness of Scp776 for Stroke as a treatment. Instead, it mentions various studies comparing other treatments like acupuncture, L-DOPA, and NeuroAiD to placebos. These studies focus on different therapies and drugs for stroke recovery, but none specifically highlight Scp776 as an effective option. Therefore, there is no direct evidence from the provided information that Scp776 is effective for stroke treatment.
12345What safety data exists for the treatment SCP-776 for stroke?
The provided research does not mention SCP-776 or any of its alternative names directly. However, it discusses the safety of GV150526, a glycine antagonist at the NMDA receptor complex, in acute stroke patients. GV150526 was generally well tolerated in early human studies, with some patients experiencing asymptomatic hyperbilirubinemia, leading to a reduction in the maintenance dose during the trial. The study concluded that GV150526 was generally well tolerated, justifying further formal efficacy studies.
678910Is the treatment Scp776 for Stroke, and the treatment Placebo, scp776 (also known as: Control, Dummy Treatment, SCP-776) a promising treatment?
Based on the information provided, there is no evidence to suggest that Scp776, also known as Control, Dummy Treatment, or SCP-776, is a promising treatment for stroke. The relevant research articles do not mention Scp776 or provide any data supporting its effectiveness for stroke treatment.
1112131415Eligibility Criteria
This trial is for adults over 18 with a body weight under 150 kg who are experiencing a severe, disabling stroke and are set to undergo endovascular thrombectomy. They must have had symptoms start within the last 16 hours and not be on certain blood thinners or have conditions that could interfere with the study.Inclusion Criteria
The time between when you last felt well and when you join the study is less than 16 hours.
I am 18 years old or older.
My body weight is under 150 kg.
+4 more
Exclusion Criteria
I am on long-term blood thinners like warfarin or apixaban.
I have end-stage kidney disease.
I do not have arterial conditions like aortic dissection or carotid stent that would interfere with blood flow restoration.
+12 more
Participant Groups
The study tests Scp776 at two different doses (1.9 mg/kg and 3.8 mg/kg) against a placebo in patients having an acute ischemic stroke to see if it's safe and can protect brain cells. It's randomized, meaning participants are put into groups by chance, double-blind so neither doctors nor patients know who gets what treatment.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: scp776 (3.8 mg/kg)Experimental Treatment1 Intervention
Cohort 2 dose regimen:
Intravenous (IV) injection(s) over 2 minutes
- 3.8 mg/kg
Group II: scp776 (1.9 mg/kg)Experimental Treatment1 Intervention
Cohort 1 dose regimen:
Intravenous (IV) slow injection(s) over 2 minutes
- 1.9 mg/kg
Group III: PlaceboPlacebo Group1 Intervention
Volume Matched Placebo (normal saline)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNM HospitalAlbuquerque, NM
Lennox Hill HospitalNew York, NY
HonorHealth Scottsdale Osborn Medical CenterScottsdale, AZ
Houston Methodist Neurological InstituteHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Silver Creek PharmaceuticalsLead Sponsor
References
Effectiveness and Superiority of Rehabilitative Treatments in Enhancing Motor Recovery Within 6 Months Poststroke: A Systemic Review. [2019]To investigate the effects of various rehabilitative interventions aimed at enhancing poststroke motor recovery by assessing their effectiveness when compared with no treatment or placebo and their superiority when compared with conventional training program (CTP).
Long-term levodopa administration in chronic stroke patients. A clinical and neurophysiologic single-blind placebo-controlled cross-over pilot study. [2022]Promising new rehabilitative approaches to improve the substantial motor disability associated with chronic stroke include pharmacotherapy to enhance motor recovery. We conducted a single-blind placebo-controlled crossover pilot study to investigate the effects of prolonged treatment with L-DOPA in stroke patients.
Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. [2019]To identify aspects of the delivery of placebo chiropractic treatments by using sham adjustments that may cause a treatment effect and that may affect the success of blinding.
Evaluating the efficacy of acupuncture in defined aspects of stroke recovery: a randomised, placebo controlled single blind study. [2021]To investigate the efficacy of acupuncture on stroke recovery compared to an inert placebo.
Chinese medicine NeuroAiD efficacy stroke recovery-extension study (CHIMES-E study): an observational multicenter study to investigate the longer-term efficacy of NeuroAiD in stroke recovery. [2013]Stroke carries a poor long-term prognosis for death and disability. There are few acute treatments that reduce death and disability after stroke. The ongoing international, multicenter, randomized, placebo-controlled, double-blind CHIMES trial is currently testing the hypothesis that a 3-month course of the traditional Chinese medicine MLC601 (NeuroAiD) is superior to placebo in reducing neurological deficit and improving functional outcome after acute ischemic stroke in patients receiving standard stroke care. This extension study tests the hypothesis that at 2 years, an initial 3-month administration of NeuroAiD is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.
New pathways for evaluating potential acute stroke therapies. [2008]Pharmacological therapy for acute ischemic stroke remains limited to one successful, approved treatment: tissue plasminogen activator within 3 h of stroke onset. Many neuroprotective drugs and a few other thrombolytics were evaluated in clinical trials, but none demonstrated unequivocal success and were approved by regulatory agencies. The development paradigm for such therapies needs to provide convincing evidence of efficacy and safety to obtain approval by the Food and Drug Administration (FDA). The FDA modernization act of 1997 stated that such evidence could be derived from one large phase III trial with a clinical endpoint and supportive evidence. Drugs being developed for acute ischemic stroke can potentially be approved under this act by coupling a major phase III trial with supportive evidence provided by a phase IIB trial demonstrating an effect on a relevant biomarker such as magnetic resonance imaging or computed tomography assessment of ischemic lesion growth. Statistical approaches have been developed to optimize the design of such an imaging-based phase IIB study, for example approaches that modify randomization probabilities to assign larger proportions of patients to the 'winning' strategy (i.e. 'pick the winner' strategies) with an interim assessment to reduce the sample size requirement. Demonstrating a treatment effect on a relevant imaging-based biomarker should provide supportive evidence for a new drug application, if a subsequent phase III trial with a clinical outcome demonstrates a significant treatment effect.
Phase II studies of the glycine antagonist GV150526 in acute stroke : the North American experience. The North American Glycine Antagonist in Neuroprotection (GAIN) Investigators. [2019]GV150526, a selective glycine site antagonist, reduces infarct volume in rats with focal cerebral ischemia. Safety and efficacy in humans with acute stroke are being investigated. We sought to further explore the safety, pharmacokinetics, and preliminary outcome of GV150526 treatment in patients with a clinical diagnosis of acute stroke.
Focal ischemia enhances the adverse effect potential of N-methyl-D-aspartate receptor antagonists in rats. [2019]Recent clinical trials with non-competitive and competitive N-methyl-D-aspartate (NMDA) receptor antagonists in patients with stroke have shown that these patients develop more adverse effects, particularly psychomimetic effects such as hallucinations and agitation, than normal volunteers at equivalent doses. We therefore examined whether such increased adverse effect potential of NMDA antagonists also occurs in a rat model of permanent focal ischemia. For this purpose, the right middle cerebral artery was occluded under halothane anesthesia, and behavioral alterations in response to the non-competitive NMDA antagonist, MK-801 (dizocilpine), were recorded after recovery from anesthesia. Behavioral alterations in ischemic rats were compared with those in sham-lesioned rats in a blinded fashion. MK-801 (0.4 mg/kg) induced psychomimetic-like stereotyped behaviors which were about twice as intense in ischemic than in non-ischemic rats. A similar trend for enhanced adverse effects was seen with the competitive NMDA antagonist CGS 19755 (Selfotel). Although more NMDA antagonists have to be tested to draw definite conclusions, the present data may indicate that enhanced sensitivity of stroke patients to adverse effects of NMDA antagonists can be predicted by use of a focal ischemia model in rats, thus allowing use of this model for developing novel cytoprotective strategies targeted to minimize glutamatergic excitotoxicity with reduced adverse effect potential.
Glycine antagonist (GV150526) in acute stroke: a multicentre, double-blind placebo-controlled phase II trial. [2022]GV150526 is a novel glycine antagonist at the NMDA receptor complex. It is a potent neuroprotective agent in animal models of acute stroke including permanent middle cerebral artery occlusion in the rat. GV150526 was very well tolerated in early human studies. The purpose of this randomised, double-blind, multicentre, placebo-controlled trial was to assess the safety and population pharmacokinetics of GV150526 in patients with a clinical diagnosis of acute stroke. Exploratory assessment of efficacy, quality of life and resource utilisation was also undertaken. Upon clinical diagnosis of acute stroke within 12 h of onset of symptoms, patients were treated with a loading dose of 800 mg GV150526 (or placebo), followed by 5 maintenance doses of 400 mg GV150526 (or placebo) given every 12 h over 3 days. Following observation of asymptomatic hyperbilirubinaemia, the maintenance dose was reduced mid-study to 200 mg. CT/MRI scanning was not mandatory prior to treatment. The study treated 128 patients (38 with GV 800 mg/400 mg, 48 with GV 800 mg/200 mg and 42 with placebo). Fewer patients with mild stroke (NIH scores or =95 at 1 month being 52, 39 and 27% in the placebo, GV 800 mg/400 mg and GV 800 mg/200 mg groups, respectively. These results probably reflect a prognostically significant baseline difference between the groups rather than the effect of GV150526. GV150526 was generally well tolerated in patients with a clinical diagnosis of acute stroke and formal efficacy studies were considered justified.
Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study. [2014]The CHIMES Study compared MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72 h. Sites from the Philippines randomized 504 of 1099 (46%) patients in the study. We aimed to define the patient characteristics and treatment responses in this subgroup to better plan future trials.
Studies of Org 10172 in patients with acute ischemic stroke. TOAST Study Group. [2018]This report presents data from pilot studies of Org 10172 in the management of patients with acute ischemic stroke. The studies have established a potentially optimal dosage and treatment regimen and have provided information for the development of a large randomized trial. The trial of Org 10172 in acute stroke treatment is now underway in the United States.
Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. [2022]For clinical trials of acupuncture, it would be desirable to have a sham procedure that is indistinguishable from the real treatment, yet inactive. A sham needle has been designed which telescopes instead of penetrating the skin. The Park Sham Device involves an improved method of supporting the sham needle and requires validation. The objective of these studies was to test whether the sham procedure using the new device was 1) indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and 2) inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. The studies were designed as subject and assessor blind, randomised controlled trials. Study 1) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke. Study 2) included 63 healthy, acupuncture naïve, adult volunteers. The interventions used were real or sham acupuncture using the Park Sham Device. Study 1) was set in a district general hospital, and study 2) in a university laboratory. The outcome measure in study 1) was the form of treatment that patients believed they had received. In study 2) the outcome measure was experience of de qi, as judged by three acupuncture experts. No patient in either group(study 1) believed he or she had been treated with the sham needle. In 40 volunteers (study 2) for whom experts achieved consensus, the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 (95% CI 2.26 to 104.86). The inter-rater reliability of all 13 experts (study 2), calculated from their judgements on 10 subjects selected by randomisation, was 0.52 (95% CI 0.19 to 0.61). In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture.
Scalp acupuncture effects of stroke studied with magnetic resonance imaging: different actions in the two stroke model rats. [2009]Scalp acupuncture (SA) therapy on strokes has been empirically established and widely used in clinics in China. The evidence from clinical studies suggests that SA produces significant benefits for some patients with stroke.
Reproduction of scalp acupuncture therapy on strokes in the model rats, spontaneous hypertensive rats-stroke prone (SHR-SP). [2019]Scalp acupuncture (SA) therapy on strokes has been empirically established and widely used in clinics in China. SA is particularly effective at ameliorating paralyses and speech disturbances, and the recovery rate is twice that for those treated with medication alone. To investigate the effects of SA on a scientific basis, we have developed a new experimental system that provides reliable controls and excludes psychological effects by using a genetic strain of rats, spontaneous hypertensive rats-stroke prone. Here we report that SA indeed has rapid and powerful effects to remove limb paralyses caused either by cerebral infarct or by cerebral haemorrhage. This model is well suited to study the mechanism of the effects of SA in parallel with clinical studies, and to describe the whole recovery process after the stroke onset.
Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial. [2022]Objective. To investigate the safety and efficacy of MLC601 (NeuroAid) as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 3 month) ischemic stroke. All patients were given either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P > .05). Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P