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Also known as pridopidine
ACR16 · 2 trials · 2 indications
The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS include dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items are rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranges from 0 to 52, with higher scores indicating more severe motor impairment.
The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS included dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items were rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranged from 0 to 52, with higher scores indicating more severe motor impairment. The last observation carried forward (LOCF) method was used to generate an mMS score for each participant for Week 12 assessment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses. |
| ACR16 45 mg | EXPERIMENTAL | Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses. |
| ACR16 90 mg | EXPERIMENTAL | Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg) |
| ACR16 10 mg BID | EXPERIMENTAL | Participants will receive ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 20 mg). |
| ACR16 22.5 mg BID | EXPERIMENTAL | Participants will receive ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 45 mg). |
| ACR16 45 mg BID | EXPERIMENTAL | Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 90 mg). |
| Name | Type | Description |
|---|---|---|
| ACR16 | DRUG | Capsules will be swallowed whole with water. |
| Placebo | DRUG | Capsules will be swallowed whole with water. |
Inclusion Criteria: * Able to provide written Informed Consent prior to any study related procedure. * Huntington's disease diagnosed with the aid of clinical features and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene. * Male or female age ≥ 30 years. * Wi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Votoplam |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE3 | Valbenazine |
| Hoffmann-La Roche | RHHBY | 3 | PHASE2 | Tominersen, RG6496, SPK-10001 |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE1 | ALN-HTT02 |
| uniQure N.V. | QURE | 2 | PHASE1 | AMT-130 |
| Sarepta Therapeutics, Inc. | SRPT | 1 | PHASE1 | SRP-1005 |
ACR16 is an investigational small molecule developed by Teva Pharmaceutical Industries for the treatment of Huntington disease, a progressive neurological disorder. It has been studied in clinical trials in adults aged 30 years and older with the condition. ACR16 is not described as approved and remains in clinical development.
ACR16 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored both of the completed clinical trials of ACR16 in Huntington disease, one conducted in the United States and Canada and the other across several European countries.
ACR16 has reached Phase 3 development for Huntington disease. Its Phase 3 trial, NCT00665223, is completed, and an earlier Phase 2 trial, NCT00724048, is also completed. Both studies have finished, and no trials of ACR16 are currently listed as active.
ACR16 has been evaluated in two completed randomized, double-blind, placebo-controlled trials in Huntington disease. NCT00724048 was a Phase 2 study enrolling 227 participants in the United States and Canada. NCT00665223 was a Phase 3 study enrolling 437 participants across Austria, Belgium, France, Germany, Italy, Portugal, Spain, and the United Kingdom.
Yes, ACR16 is also known as pridopidine. Both completed trials of ACR16 in Huntington disease are titled using the name pridopidine, so searches for either name refer to the same investigational small molecule being developed by Teva Pharmaceutical Industries for Huntington disease.
The two completed ACR16 trials in Huntington disease enrolled a combined total of 664 participants. The Phase 2 trial NCT00724048 enrolled 227 participants, and the Phase 3 trial NCT00665223 enrolled 437 participants. Both studies were randomized, double-blind, and placebo-controlled, and included adults aged 30 years and older.