Muscle CrampsNCT02221570
Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
A study testing Baclofen in people with Muscle Cramps and Liver Cirrhosis, run by Tanta University at 1 site in Egypt.
Trial summary
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Muscle Cramps, Liver Cirrhosis
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Nov 2014
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis
- Muscle cramps( ≥3 cramps per week )
Who cannot join
- Allergy to baclofen
- Renal impairment
- Pregnant and lactating women
- Peripheral vascular disease
- Peripheral neuropathy
- Medications as calcium channel blockers, conjugated estrogens and naproxen.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, Gharbia Governorate
Asem A Elfert, MD, +20-122-437-8188, asem1967@yahoo.com
Asem A Elfert, MD
About this study
Official title: A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life.
The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.
Read the detailed description
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes.
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.
Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.
- Conditions
- Muscle Cramps, Liver Cirrhosis
- Being tested
- Baclofen
- Medical subject headings
- Muscle Cramp, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called Gablofen, Lioresal, Apo-Baclofen, Dom-Baclofen
Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Active comparator | Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough. Receives: Drug: Baclofen |
| Placebo | Placebo comparator | placebo of baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Muscle CrampsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Shebl, Tanta University
- Investigators
- Asem A Elfert, MD, Principal investigator, Tanta Faculty of Medicine, ProfessorLobna A AboAli, Study director, Tanta Faculty of Medicine, LecturerSamah M Soliman, Study director, Tanta Faculty of Medicine, LecturerIbrahim Shebl, Study director, Tanta University Hospitals, House Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221570
- Sponsor's protocol ID
- baclofen cramps
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.
PubMed 22835465Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.
PubMed 23542334Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.
PubMed 4938243Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.
PubMed 11252142Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.
PubMed 22404184Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.
PubMed 3185643Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.
PubMed 20655477
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT02221570
- Acronym / sponsor ID
- baclofen cramps
- Conditions
- Muscle Cramps, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- 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.
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life.
The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.
Detailed description
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes.
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.
Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Active comparator | Drug: BaclofenBaclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough. |
| Placebo | Placebo comparator | –placebo of baclofen |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis
- Muscle cramps( ≥3 cramps per week )
Key exclusion criteria (6 listed)
- Allergy to baclofen
- Renal impairment
- Pregnant and lactating women
- Peripheral vascular disease
- Peripheral neuropathy
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 |
|---|---|---|
| BaclofenAlso: Gablofen, Lioresal, Apo-Baclofen, Dom-BaclofenBaclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough. | Drug | Baclofen |
Primary outcome
Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Background: PubMed 22835465Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.
- Background: PubMed 23542334Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.
- Background: PubMed 4938243Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.
- Background: PubMed 11252142Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.
- Background: PubMed 22404184Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.
- Background: PubMed 3185643Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.
- Background: PubMed 20655477Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.
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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.
Asem A Elfert, MD principal investigator
Tanta Faculty of Medicine, Professor
Lobna A AboAli study director
Tanta Faculty of Medicine, Lecturer
Samah M Soliman study director
Tanta Faculty of Medicine, Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baclofen in people with Muscle Cramps and Liver Cirrhosis, run by Tanta University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asem A Elfert, MD (+20-122-437-8188, asem1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221570, which also lists 7 linked publications.
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 6 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.