Upper Limb SpasticityPhase 1NCT05956509
Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity
A Phase 1 study testing ABBV-950 and BOTOX in people with Upper Limb Spasticity, run by AbbVie at 9 sites in United States.
Trial summary
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- ABBV-950 and BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Jan 2024to 2 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of upper limb spasticity due to stroke, with most recent stroke occurring at least 12 weeks prior to the Screening visit.
- Modified Ashworth Scale-Bohannon (MAS-B) score of >= 3 in the wrist flexors, and a score of >= 1+ in the finger flexors and MAS-B score of >= 2 elbow flexors at both Screening and Visit 2 (Baseline).
Who cannot join
- Additional strokes in the 12 weeks preceding the most recent stroke and in the opinion of the investigator, is not at significant risk of experiencing another stroke during the study period.
- Spasticity in the contralateral upper limb that requires treatment.
- Presence of fixed contractures in muscles of wrist, elbow, fingers.
- Botulinum toxin treatment of any serotype in the 20 weeks prior to Day for upper limb spasticity and in the 12 weeks prior to Day 1 for any indication other than upper limb spasticity.
- Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months.
- Injection of corticosteroids or anesthetics in the study limb within 12 weeks.
- Casting of the upper limbs within 12 weeks.
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
North County Neurology Associates /ID# 256333
Carlsbad, California, 92011-4213
University of Missouri Hospital /ID# 255310
Columbia, Missouri, 65212
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 255328
Dallas, Texas, 75235-7709
Rancho Los Amigos National Rehabilitation center /ID# 255335
Downey, California, 90242
Neuro Pain Medical Center /ID# 256036
Fresno, California, 93710-5473
JEM Research Institute /ID# 258782
Lake Worth, Florida, 33462-1141
Kansas Institute of Research /ID# 254998
Overland Park, Kansas, 66211-1363
New England Institute for Clinical Research /ID# 255020
Stamford, Connecticut, 06905
MedStar National Rehabilitation Hospital /ID# 255630
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Efficacy, and Tolerability of ABBV-950 for the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. Common causes of spasticity include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. This study will assess how safe and effective ABBV-950 is in treating upper limb spasticity in adult post-stroke participants. Adverse events and change in symptoms will be assessed.
ABBV-950 in an investigational drug being developed for treating spasticity. This study is conducted in 2 parts. In Part 1, participants are assigned to receive different doses of ABBV-950 or placebo. There is 1 in 4 chance that participants will be assigned to receive placebo. In Part 2, participants will be randomly assigned to receive BOTOX, ABBV-950, or placebo. There is 1 in 5 chance for participants to receive placebo. Approximately 297 adult post-stroke participants with upper limb spasticity will be enrolled at approximately 50 sites in the United States.
Read more
In Part 1, participants will receive intramuscular (IM) injections of ABBV-950 or placebo on Day 1. In Part 2, participants will receive IM injections of BOTOX, ABBV-950, or placebo on Day 1. All participants will be followed for 24 weeks.
There may be higher treatment burden for participants in this trial compared to the standard of care. Participants will attend regular clinic visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
- Conditions
- Upper Limb Spasticity
- Being tested
- ABBV-950, BOTOX, Placebo for ABBV-950
- Keywords
- Spasticity, Upper Limb Spasticity, Stroke, ABBV-950, Botulinum toxin type A
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-950Biological
Also called Botulinum toxin type A
Intramuscular (IM) Injection
BOTOXBiological
Also called OnabotulinumtoxinA
Intramuscular (IM) Injection
Placebo for ABBV-950Drug
Intramuscular (IM) Injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-950 Dose A | Experimental | Participants will receive ABBV-Dose A on Day 1. Receives: Biological: ABBV-950 |
| Part 1: Placebo for ABBV-950 Dose A | Placebo comparator | Participants will receive placebo for ABBV-950 on Day 1. Receives: Drug: Placebo for ABBV-950 |
| Part 1: ABBV-950 Dose B | Experimental | Participants will receive ABBV-950 Dose B on Day 1. Receives: Biological: ABBV-950 |
| Part 1: Placebo for ABBV-950 Dose B | Placebo comparator | Participants will receive placebo for ABBV-950 on Day 1. Receives: Drug: Placebo for ABBV-950 |
| Part 1: ABBV-950 Dose C | Experimental | Participants will receive ABBV-950 Dose C on Day 1. Receives: Biological: ABBV-950 |
| Part 1: Placebo for ABBV-950 Dose C | Placebo comparator | Participants will receive placebo for ABBV-950 on Day 1. Receives: Drug: Placebo for ABBV-950 |
| Part 2: BOTOX Dose A | Active comparator | Participants will receive BOTOX Dose A on Day 1. Receives: Biological: BOTOX |
| Part 2: ABBV-950 Dose A | Experimental | Participants will receive ABBV-950 Dose A on Day 1. Receives: Biological: ABBV-950 |
| Part 2: ABBV-950 Dose B | Experimental | Participants will receive ABBV-950 Dose B on Day 1. Receives: Biological: ABBV-950 |
| Part 2: ABBV-950 Dose C | Experimental | Participants will receive ABBV-950 Dose C on Day 1. Receives: Biological: ABBV-950 |
| Part 2: Placebo for ABBV-950 | Placebo comparator | Participants will receive placebo for ABBV-950 on Day 1. Receives: Drug: Placebo for ABBV-950 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B)
MAS-B measures muscle tone based on grading the resistance encountered in a specific muscle group by means of passively moving a limb through its range of motion at a study-specified velocity. Score ranges from 0 (No increase in muscle tone) through 4 (Affected part(s) rigid in flexion or extension).
Measured: Up to Week 6
Number of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to Week 24
Secondary outcomes (3)
Change in Clinician Global Impression of Change (CGI-C) Score
CGI-C is a 9-point rating scale used to measure the clinician's impression of overall treatment response since the first dose of study intervention. CGI-C scores range from -4 = very marked worsening to +4 = very marked improvement.
Measured: Up to Week 6
Change in Clinician Global Impression of Severity (CGI-S) Score
CGI-S is a 5-point rating scale used to measure the clinician's or trained personnel's impression of the current severity of the participant's upper limb spasticity. Scores range from 0 = no spasticity to 4 = very severe.
Measured: Up to Week 6
Percentage of Participants Achieving Wrist MAS-B Responder Status
MAS-B measures muscle tone based on grading the resistance encountered in a specific muscle group by means of passively moving a limb through its range of motion at a study-specified velocity. Score ranges from 0 (No increase in muscle tone) through 4 (Affected part(s) rigid in flexion or extension). Responder is defined as participant with >= 1 grade improvement from baseline.
Measured: Up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start12 Jan 2024
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb SpasticityStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956509
- Sponsor's protocol ID
- M23-499
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Efficacy, and Tolerability of ABBV-950 for the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT05956509
- Acronym / sponsor ID
- M23-499
- Conditions
- Upper Limb Spasticity
- Keywords
- Spasticity, Upper Limb Spasticity, Stroke, ABBV-950, Botulinum toxin type A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. Common causes of spasticity include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. This study will assess how safe and effective ABBV-950 is in treating upper limb spasticity in adult post-stroke participants. Adverse events and change in symptoms will be assessed.
ABBV-950 in an investigational drug being developed for treating spasticity. This study is conducted in 2 parts. In Part 1, participants are assigned to receive different doses of ABBV-950 or placebo. There is 1 in 4 chance that participants will be assigned to receive placebo. In Part 2, participants will be randomly assigned to receive BOTOX, ABBV-950, or placebo. There is 1 in 5 chance for participants to receive placebo. Approximately 297 adult post-stroke participants with upper limb spasticity will be enrolled at approximately 50 sites in the United States.
In Part 1, participants will receive intramuscular (IM) injections of ABBV-950 or placebo on Day 1. In Part 2, participants will receive IM injections of BOTOX, ABBV-950, or placebo on Day 1. All participants will be followed for 24 weeks.
There may be higher treatment burden for participants in this trial compared to the standard of care. Participants will attend regular clinic visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-950 Dose A | Experimental | Biological: ABBV-950Participants will receive ABBV-Dose A on Day 1. |
| Part 1: Placebo for ABBV-950 Dose A | Placebo comparator | Drug: Placebo for ABBV-950Participants will receive placebo for ABBV-950 on Day 1. |
| Part 1: ABBV-950 Dose B | Experimental | Biological: ABBV-950Participants will receive ABBV-950 Dose B on Day 1. |
| Part 1: Placebo for ABBV-950 Dose B | Placebo comparator | Drug: Placebo for ABBV-950Participants will receive placebo for ABBV-950 on Day 1. |
| Part 1: ABBV-950 Dose C | Experimental | Biological: ABBV-950Participants will receive ABBV-950 Dose C on Day 1. |
| Part 1: Placebo for ABBV-950 Dose C | Placebo comparator | Drug: Placebo for ABBV-950Participants will receive placebo for ABBV-950 on Day 1. |
| Part 2: BOTOX Dose A | Active comparator | Biological: BOTOXParticipants will receive BOTOX Dose A on Day 1. |
| Part 2: ABBV-950 Dose A | Experimental | Biological: ABBV-950Participants will receive ABBV-950 Dose A on Day 1. |
| Part 2: ABBV-950 Dose B | Experimental | Biological: ABBV-950Participants will receive ABBV-950 Dose B on Day 1. |
| Part 2: ABBV-950 Dose C | Experimental | Biological: ABBV-950Participants will receive ABBV-950 Dose C on Day 1. |
| Part 2: Placebo for ABBV-950 | Placebo comparator | Drug: Placebo for ABBV-950Participants will receive placebo for ABBV-950 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of upper limb spasticity due to stroke, with most recent stroke occurring at least 12 weeks prior to the Screening visit.
- Modified Ashworth Scale-Bohannon (MAS-B) score of >= 3 in the wrist flexors, and a score of >= 1+ in the finger flexors and MAS-B score of >= 2 elbow flexors at both Screening and Visit 2 (Baseline).
Key exclusion criteria (8 listed)
- Additional strokes in the 12 weeks preceding the most recent stroke and in the opinion of the investigator, is not at significant risk of experiencing another stroke during the study period.
- Spasticity in the contralateral upper limb that requires treatment.
- Presence of fixed contractures in muscles of wrist, elbow, fingers.
- Botulinum toxin treatment of any serotype in the 20 weeks prior to Day for upper limb spasticity and in the 12 weeks prior to Day 1 for any indication other than upper limb spasticity.
- Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-950Also: Botulinum toxin type AIntramuscular (IM) Injection | Biological | Part 1: ABBV-950 Dose A, Part 1: ABBV-950 Dose B, Part 1: ABBV-950 Dose C, Part 2: ABBV-950 Dose A, Part 2: ABBV-950 Dose B, Part 2: ABBV-950 Dose C |
| BOTOXAlso: OnabotulinumtoxinAIntramuscular (IM) Injection | Biological | Part 2: BOTOX Dose A |
| Placebo for ABBV-950Intramuscular (IM) Injection | Drug | Part 1: Placebo for ABBV-950 Dose A, Part 1: Placebo for ABBV-950 Dose B, Part 1: Placebo for ABBV-950 Dose C, Part 2: Placebo for ABBV-950 |
Primary outcome
Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B)
Time frame: Up to Week 6
MAS-B measures muscle tone based on grading the resistance encountered in a specific muscle group by means of passively moving a limb through its range of motion at a study-specified velocity. Score ranges from 0 (No increase in muscle tone) through 4 (Affected part(s) rigid in flexion or extension).
Number of Participants Experiencing Adverse Events
Time frame: Up to Week 24
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
3 secondary outcomes
Change in Clinician Global Impression of Change (CGI-C) Score
Time frame: Up to Week 6
Change in Clinician Global Impression of Severity (CGI-S) Score
Time frame: Up to Week 6
Percentage of Participants Achieving Wrist MAS-B Responder Status
Time frame: Up to Week 6
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-950 and BOTOX in people with Upper Limb Spasticity, run by AbbVie at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B) (time frame: Up to Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.