NCT01681940 is a Phase 2 clinical trial of Lamazym in Alpha-Mannosidosis, sponsored by Zymenex A/S.

Who is sponsoring NCT01681940?

NCT01681940 is sponsored by Zymenex A/S.

What drugs are being tested in NCT01681940?

Interventions in NCT01681940: Lamazym.

What condition does NCT01681940 study?

NCT01681940 studies Alpha-Mannosidosis.

Is NCT01681940 still recruiting?

NCT01681940 is currently completed. Last updated 28 March 2017.

Last reviewed 2017-03-28 · How we verify

NCT01681940

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multi-Center, Open-Label Trial of the Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis

Completed Phase 2 Last updated 28 March 2017

What this trial tests

Phase 2 trial testing Lamazym in Alpha-Mannosidosis in 10 participants. Completed in 1 September 2013.

Timeline

1 January 2012

Primary endpoint
1 August 2012

1 September 2013

Quick facts

Lead sponsor	Zymenex A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 January 2012
Primary completion	1 August 2012
Estimated completion	1 September 2013
Sites	4 locations across Belgium, Denmark, Spain, United Kingdom

Drugs / interventions tested

Lamazym — full drug profile →

Conditions studied

Alpha-Mannosidosis — all drugs for Alpha-Mannosidosis →

Sponsor

Zymenex A/S — full company profile →

Who can join

Adults 5 to 21, any sex, with Alpha-Mannosidosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Reduction of Oligosaccharides in blood serum
Time frame: 6 months
Efficacy endpoint evaluation as change from baseline

Sponsor's own description

The overall objective is to evaluate the long-term efficacy, safety and tolerability of repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.
Borgwardt L, Guffon N, Amraoui Y, Dali CI, et al · · 2018 · cited 43× · PMID 29846843 · DOI 10.1007/s10545-018-0185-0
Extended long-term efficacy and safety of velmanase alfa treatment up to 12 years in patients with alpha-mannosidosis.
Guffon N, Borgwardt L, Tylki-Szymańska A, Ballabeni A, et al · · 2025 · cited 6× · PMID 39381850 · DOI 10.1002/jimd.12799
Relationship between <i>MAN2B1</i> genotype/subcellular localization subgroups, antidrug antibody detection, and long-term velmanase alfa treatment outcomes in patients with alpha-mannosidosis.
Borgwardt LG, Ceravolo F, Zardi G, Ballabeni A, et al · · 2023 · cited 5× · PMID 36873087 · DOI 10.1002/jmd2.12349
Can velmanase alfa be the next widespread potential therapy for alpha-mannosidosis?
Abdul Ghani S, Burney S, Ul Hussain H, Abdul Wahid M, et al · · 2023 · cited 2× · PMID 37352513 · DOI 10.1097/js9.0000000000000528

Verify or expand the search:

Other recruiting trials for Alpha-Mannosidosis

Currently open trials in the same condition.

NCT02171104 — MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis · Phase 2 · active not recruiting

Other Zymenex A/S trials

Trials by the same sponsor.

NCT00418795 — Porphozym in the Treatment of Acute Attacks in AIP · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01681940 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zymenex A/S
Last refreshed: 28 March 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01681940.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing